TMF Specialist - (Levels I-III) 5 Openings (Levels I-III)

Piper Health & Sciences is seeking a TMF Specialist to join a leading full-service Contract Research Organization (CRO) on a full-time basis, attending the job onsite at their facility located in the greater Washington, DC/Montgomery County area. The TMF Specialist will support Trial Master File (TMF) activities across clinical trials, ensuring regulatory compliance, inspection readiness, and adherence to global TMF standards.

This role is ideal for TMF professionals who thrive in fast-paced CRO environments and enjoy maintaining inspection‑ready TMFs across multiple clinical studies.

Please note this is a full-time, hybrid position, with 2 onsite days and 3 remote days per week. The role is open to Level I, II, and III candidates, depending on experience, with increasing responsibility and leadership expectations at higher levels. There are five (5) TMF openings available, and referrals are welcome.

Responsibilities of the TMF Specialist Includes:

• Support day-to-day Trial Master File (TMF) operations across assigned clinical studies
• Perform TMF review, reconciliation, and quality control activities to ensure completeness, accuracy, and inspection readiness
• Ensure TMF compliance with FDA, ICH, and EMA regulatory requirements
• Utilize electronic TMF systems, including Veeva Vault, Trial Interactive, or similar platforms
• Conduct TMF monitoring, including ongoing oversight of document completeness and timeliness
• Develop, maintain, and execute TMF Plans and TMF Indexes in accordance with study requirements
• Identify TMF gaps, risks, and trends; collaborate with study teams to drive timely resolution
• Support audit and inspection readiness activities, including documentation review and response to TMF findings
• Generate and maintain TMF metrics and documentation to support compliance and quality initiatives

Additional Level-Based Responsibilities:

Level II

• Provide oversight and mentoring to junior TMF staff participating in TMF reviews
• Support training initiatives and provide procedural guidance on TMF processes

Level III

• Manage and oversee TMF staff, including workload planning and performance guidance
• Lead the development and maintenance of foundational TMF documents, including:
  • TMF Plans
  • TMF Indexes
  • SOPs and other governing documents
• Serve as a TMF subject matter expert, supporting inspection readiness and continuous improvement initiatives

Qualifications of the TMF Specialist Includes:

• Bachelor’s degree (B.A. or B.S.) in a science, healthcare, or related field (required)
• TMF experience aligned with one of the following levels:
  • Level I: 0–2 years of relevant TMF or clinical operations experience
  • Level II: 2–4 years of TMF experience, including mentoring or oversight of junior staff
  • Level III: 4+ years of TMF experience, including team management and document governance responsibilities
• Strong working knowledge of Trial Master File requirements and applicable global regulations (FDA, ICH, EMA)
• Hands-on experience with eTMF systems, with emphasis on Veeva Vault and Trial Interactive
• Demonstrated experience conducting TMF reviews and supporting inspection readiness
• High attention to detail with strong organizational and time‑management skills
• Excellent written and verbal communication skills
• Ability to work effectively in a hybrid environment and collaborate with cross‑functional clinical teams

Compensation of the TMF Specialist Includes:

• Pay Range: $41,600.00 - $56,160.00 per year (equivalent to $20.00 - $27.00 per hour), based on experience and certifications.
• Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401k through ADP, sick leave as required by law.

This job opens for applications on 1/22/2026. Applications for this job will be accepted for at least 30 days from the posting date.

#LI-AW1

#LI-HYBRID

keywords: TMF Operations, eTMF Systems, Veeva Vault, Trial Interactive, FDA Compliance, ICH Guidelines, EMA Regulations, GCP, Clinical Documentation, CRO Experience, TMF Specialist, Trial Master File, eTMF, TMF Operations, TMF Management, TMF Review, TMF Quality Control, TMF Compliance, TMF Monitoring, TMF Oversight, TMF Governance, TMF Reconciliation, TMF Inspection Readiness, TMF Metrics, TMF Documentation, Clinical Trial Documentation, Clinical Operations, Clinical Research, CRO, Contract Research Organization, Regulatory Compliance, FDA Regulations, ICH Guidelines, EMA Requirements, GCP, Good Clinical Practice, Audit Readiness, Inspection Support, Quality Assurance, Document Management, Electronic Document Management Systems, eClinical Systems, Veeva Vault, Trial Interactive, Veeva eTMF, Life Sciences Technology, Clinical Systems, Study Start-Up Support, Study Close-Out Support, Risk-Based TMF Management, TMF Plans, TMF Indexes, SOP Development, SOP Compliance, Process Improvement, Vendor Oversight, Cross-Functional Collaboration, Study Team Support, Attention to Detail, Organizational Skills, Time Management, Multitasking, Written Communication, Verbal Communication, Stakeholder Communication, Data Integrity, Compliance Monitoring, Quality Metrics, Mentorship, Staff Oversight, Team Leadership, People Management, Training and Coaching, Hybrid Work Environment, Clinical Documentation Specialist, TMF Manager, Senior TMF Specialist, TMF Associate, TMF Lead, Clinical Trial Associate, Clinical Operations Specialist, Regulatory Operations Specialist, Clinical Compliance Specialist